Z-2654-2026 Class II Ongoing
FDA device recall Z-2654-2026 was initiated by BD SWITZERLAND SARL on June 4, 2026 and is designated Class II. Reason for recall: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. The recall status is ongoing. Affected quantity: 50 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- June 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 devices
Product Description
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Reason for Recall
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Distribution Pattern
U.S.: IL O.U.S: N/A
Code Information
Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445